Analytical tool, analytical tool pack, cartridge including plurality of packs, method of making analytical tool pack, analyzer, and mechanism for taking out object

ABSTRACT

The present invention relates to an analytical tool pack ( 1 ) including an analytical tool ( 13 ) accommodated in one or between a plurality of sealing sheets ( 12   a,    12   b ). The analytical tool pack ( 1 ) includes a stopper portion ( 146 ) for holding the analytical tool ( 13 ) with the analytical tool ( 13 ) caused to project from the sealing sheets ( 12   a,    12   b ). Preferably, the analytical tool pack ( 1 ) further comprises a base film ( 14 ) bonded to the sealing sheets ( 12   a,    12   b ). For example, the stopper portion ( 146 ) comprises the bonded portion of the sealing sheets ( 12   a,    12   b ) and the base film ( 14 ). The present invention further relates to an analyzer which uses the analytical tool pack ( 1 ). The analyzer comprises an opening mechanism for making a cut ( 15 ) in the analytical tool pack ( 1 ), and a pushing mechanism for moving the analytical tool ( 13 ) relative to the sealing sheets ( 12   a,    12   b ) to cause the analytical tool ( 13 ) to project through the cut ( 15 ).

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a Division of U.S. Ser. No. 10/515,713 filed Nov.23, 2004, which is a U.S. National Stage of PCT/JP03/06240, filed May19, 2003, which applications are incorporated herein by reference.

TECHNICAL FIELD

The present invention mainly relates to a technique for analyzing aparticular component in a sample liquid. It also relates to a techniquefor taking out an object from an object-containing pack such as ananalytical tool pack.

BACKGROUND ART

For diabetics, it is preferable to regularly measure his or her ownglucose level in blood and take appropriate measures such as medicineadministration in accordance with the measurements. JP-A-H08-262026 andJP-A-2001-33418, for example, disclose devices for measuring a bloodglucose level.

As shown in FIG. 45, in a first device disclosed in JP-A-H08-262026,when an operation portion 91 provided on a housing 90 is operated, asensor S partially projects through an opening 90 a formed at the frontend of the housing 90. In the first device, when the blood of the useris applied to a predetermined portion of the sensor S, the measurementcircuit (not shown) in the housing 90 computes the glucose level inblood, and the measurement result is displayed on a display 92.

As shown in FIG. 46, in the first device, the sensor S is accommodatedin the housing 90 as a package (cartridge) 95. The package 95 includes abase member 95 a formed with a plurality of radially extending recesses96, and a film 95 b bonded to the base member. Each of the recess 96serves to accommodate a sensor S.

As shown in FIGS. 47A and 47B, when the operation portion 91 is operatedto take out the sensor S, a blade 97 a breaks through part of the film95 b of the package 95 and then pushes the rear end of the sensor Stoward the outer circumference of the package 95. As a result, thesensor S breaks through part of the film 95 b and is pushed to theopening 90 a of the housing 90.

With such a structure, by setting the package 95 in the housing 90,measurement of the glucose level in blood can be performed a pluralityof times by successively using the plurality of sensors S.

In the first device, when the sensor S is taken out from the package 95,the sensor S itself breaks through the film 95 b. Therefore, the frontend of the sensor S needs to be made sharp. However, since the user maytouch the front end of the sensor S, the sharp front end may cause theuser to fear and hence is not preferable. Moreover, the sensor S may notbreak the film 95 b easily, so that taking out of the sensor S bybreaking the film 95 b by the sensor S itself is sometimes difficult.

In a second device disclosed in JP-A-2001-33418, a film memberaccommodating a sensor is placed in a device. The sensor is taken out bybreaking the film and used for measuring a blood glucose level, forexample.

In the second device, the sensor is taken out from the film member, andthe measurement is performed. Therefore, the number of parts which needbe disposed of after the measurement is large. That is, two parts, i.e.the empty film member and the sensor need be disposed of. Moreover,since the timing at which the film becomes unnecessary does not coincidewith the timing at which the sensor becomes unnecessary, the two partsneed be disposed of separately, which is inconvenient.

DISCLOSURE OF THE INVENTION

A first object of the present invention is to make it possible toproperly take out a stored object such as a sensor without making sharpthe front end of the stored object. A second object of the presentinvention is to reduce the burden of disposing of the used parts afterthe analysis.

According to a first aspect of the present invention, there is providedan analytical tool pack comprising a wrapping member made of a sealingsheet, and an analytical tool accommodated in the wrapping member. Theanalytical tool pack further comprises a stopper portion for holding theanalytical tool with the analytical tool caused to project from thewrapping member.

The sealing sheet may comprise a pair of sheet elements or a singlesheet. When the sealing sheet comprises a pair of sheet elements, thewrapping member is formed by directly or indirectly bonding the pairedsheet elements to each other at the peripheries thereof. When thesealing sheet comprises a single sheet, the wrapping member may beformed by folding the sheet.

Preferably, the wrapping member further comprises a base film bonded tothe sealing sheet. For example, in this case, the stopper portioncomprises the bonded portion of the sealing sheet and the base film.

Preferably, the analytical tool includes an engagement portion forengaging with the stopper portion.

Preferably, at least one of the sealing sheet and the base film retainsdesiccant. The desiccant may be contained in the sealing sheet and thebase film or applied to the surfaces thereof. Alternatively, thedesiccant may be held by the base film or the analytical tool.

Preferably, the analytical tool is caused to project through a cutformed in the sealing sheet by using a cutter, and the base filmincludes a through-hole for allowing the insertion of the cutter.

Preferably, the analytical tool includes an end which is caused toproject through a cut formed in the sealing sheet by using a cutter, andthe end is entirely rounded.

Preferably, the analytical tool is moved relative to the wrapping memberby using a pushing member, the base film includes a through-hole forallowing the movement of the pushing member, and the analytical toolfurther includes an engagement portion for engaging the pushing member.

The through-hole of the base member may have an outline which is in theform of a closed loop or an outline which is partially cut away (i.e.,part of the through-hole is open to a side of the base film).

Preferably, the analytical tool includes a substrate, a plurality ofelectrodes formed on the substrate, and a plurality of holes each forpartially exposing a respective one of the electrodes selectively. Theelectrodes may be continuously exposed.

Preferably, the analytical tool pack of the present invention furthercomprises an information providing portion for outputting informationrelating to the analytical tool. For example, the information providingportion is capable of outputting information by the combination ofconduction/non-conduction between a plurality of pairs of conductors, orby correlation with a resistance between conductors, or by correlationwith locations where a projection and a recess are formed.

For example, the analytical tool pack in use is loaded in anaccommodation portion of an analyzer. Preferably, in this case, theanalytical tool pack further comprises a pack orientation checker forpreventing improper loading of the analytical tool into theaccommodation portion. Preferably, the analytical tool caused to projectfrom the wrapping member can be restored in the wrapping member foraccommodation again.

According to a second aspect of the present invention, there is providedan analytical tool pack comprising a wrapping member, and an analyticaltool accommodated in the wrapping member, the analytical tool packfurther comprising an information providing portion for outputtinginformation relating to the analytical tool.

For example, the information providing portion is capable of outputtinginformation by the combination of conduction/non-conduction between aplurality of pairs of conductors, or by correlation with a resistancebetween conductors, or by correlation with locations where a projectionand a recess are formed. Preferably, the information providing portionis provided at an obverse surface of the wrapping member.

According to a third aspect of the present invention, there is providedan analytical tool accommodated in a wrapping member for providing ananalytical tool pack and caused to project from the wrapping member inuse, the analytical tool pack including a stopper portion for holdingthe analytical tool. The analytical tool includes an engagement portionfor engaging with the stopper portion.

According to a fourth aspect of the present invention, there is providedanalytical tool accommodated in a wrapping member for providing ananalytical tool pack and caused to project from the wrapping member inuse, the analytical tool pack being capable of moving the analyticaltool relative to the wrapping member by using a pushing member. Theanalytical tool includes an engagement portion for engaging with thepushing member.

According to a fifth aspect of the present invention, there is providedan analytical tool accommodated in a wrapping member for providing ananalytical tool pack and including an end which is caused to projectfrom the wrapping member in use of the analytical tool, and the end isentirely rounded.

According to a sixth aspect of the present invention, there is provideda cartridge including a container accommodating a plurality ofanalytical tool packs, each of the analytical tool packs including awrapping member, and an analytical tool accommodated in the wrappingmember. The container is formed with a through-hole communicating withthe inside of the container and utilized for pushing out the analyticaltool pack accommodated in the container.

Preferably, the plurality of analytical tool packs are bundled in thecontainer. For example, the analytical tool packs are bundled togetherby applying an adhesive element on a surface of each tool pack andstacking the packs for bonding together, by maintaining the stackedstate of tool packs by using a member in the form of a strip, orconnecting side surfaces of the stacked analytical tool packs by usingan adhesive sheet.

According to a seventh aspect of the present invention, there isprovided a method of making an analytical tool pack comprising the stepsof placing an analytical tool on a punch film or a sealing film, andbonding the sealing film to the punch film. The analytical tool is keptat an appropriate position relative to the punch film at least for atime period from when the placing step is completed and till when thebonding step is started.

For example, the position keeping is performed by using a suction unit.

According to an eighth aspect of the present invention, there isprovided a method of making an analytical tool pack comprising fixing ananalytical tool to a sealing film or a punch film. The fixing step isperformed simultaneously with respect to a plurality of analytical toolsby using a plurality of pressing heads, and the pressing heads arecapable of setting respective heights individually.

According to a ninth aspect of the present invention, there is providedan analyzer for analyzing a sample by using an analytical tool packincluding a wrapping member and an analytical tool accommodated in thewrapping member, the analysis being performed with the analytical toolcaused to project from the wrapping member. The analyzer comprises anopening mechanism for making a cut in the wrapping member, and a pushingmechanism for moving the analytical tool relative to the wrapping memberto cause the analytical tool to project through the cut.

Preferably, the analyzer of the present invention obtains outputrelating to analysis results from the analytical tool, with theanalytical tool caused to project from the wrapping member.

For example, the pushing mechanism comprises a first and a secondmembers which are movable relative to each other in a first direction,and a pushing member which is movable in a second direction crossing thefirst direction in accordance with the relative movement between thefirst and the second members, the pushing member serving to move theanalytical tool relative to the wrapping member.

For example, the pushing member is pivotally fixed to the first memberwhile being connected to the second member for relative movement to thesecond member. Preferably, in this case, the second member is providedwith a guide for moving a portion connected to the pushing member in thesecond direction. Preferably, the pushing member comprises a blade.

For example, the pushing mechanism further comprises a holder for movingthe wrapping member together with the first member or the second member.Preferably, in this case, the pushing mechanism further comprises areleaser for releasing the holding of the analytical tool by the holder.

For example, the releaser increases the distance between the firstmember and the second member in the second direction when a particularpositional relationship is established between the first member and thesecond member.

Preferably, the analyzer of the present invention further comprises arestorer for restoring the analytical tool projected from the wrappingmember into the wrapping member for accommodation again.

Preferably, the restorer is provided by the pushing member.

In the analyzer of the present invention, the second member performsreciprocating movement between a first predetermined position and asecond predetermined position relative to the first member twice in asingle sample analysis operation. In this case, the pushing memberengages and moves the analytical tool to cause the analytical tool toproject from the wrapping member when the second member moves from thefirst position toward the second position in the first reciprocatingmovement. On the other hand, when the pushing member engages and movesthe analytical tool to restore the analytical tool into the wrappingmember when the second member moves from the second position toward thefirst position in the second reciprocating movement.

In this case, it is preferable that the second member is provided with acam groove for controlling the operation of the pushing member. Forexample, the cam groove has a configuration which makes the pushingmember operate differently during the first reciprocating movement andduring the second reciprocating movement.

As the analytical tool pack, use may be made of one in which thewrapping member comprises a sealing sheet, and a base film formed with athrough-hole and bonded to the sealing sheet. In this case, the openingmechanism includes a cutter for making a cut in the wrapping member, andthe cutter and the pushing member move through the through-hole.

For example, the opening mechanism includes an operation button, and acutter which moves together with the operation button.

For example, the analyzer of the present invention may further comprisean accommodation portion into which the analytical tool pack is to beloaded. Preferably, in this case, the accommodation portion includes apack orientation checker for preventing improper loading of theanalytical tool pack into the accommodation portion.

For example, the analyzer of the present invention comprises a devicebody including an accommodation portion for accommodating a plurality ofanalytical tool packs, and a lid connected to the device body. Theanalytical tool packs are accommodated while being pressed against eachother by a pressing member. Preferably, in this case, the lid isconnected to the pressing member to release the pressing of theanalytical tool packs in opening the accommodation portion.

According to a tenth aspect of the present invention, there is providedan object taking-out mechanism for taking out an object from a pack inwhich the object is accommodated in a wrapping member. The mechanismcomprises an opening mechanism for making a cut in the wrapping member,and a pushing mechanism for pushing out the object through the cut.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an entire perspective view showing an analyzer according to afirst embodiment of the present invention.

FIG. 2 is a perspective view showing the analyzer of FIG. 1 in the statein which the lid is opened.

FIG. 3 is a sectional view showing a principal portion of the analyzerof FIG. 1.

FIG. 4A is a sectional view of the analyzer shown in FIG. 1, whereasFIG. 4B is a sectional view of the state in which the lid is opened inthe analyzer.

FIG. 5A is a sectional view taken along lines Z1-Z1 in FIG. 4A, whereasFIG. 5B is a sectional view corresponding to FIG. 5A for showing anotherexample of sensor pack.

FIG. 6 is an exploded perspective view of a sensor cartridge.

FIG. 7 is a sectional view of a sensor cartridge.

FIG. 8A-8C each is a perspective view for showing a manner of bundlingof a plurality of sensor packs.

FIG. 9 is an entire perspective view of a sensor pack.

FIG. 10A is a sectional view taken along lines Z2-Z2 in FIG. 9, whereasFIG. 10B is a sectional view taken along lines Z3-Z3 in FIG. 9.

FIGS. 11A and 11B are perspective views for describing the operation forforming a cut in the sensor pack.

FIGS. 12A and 12B are perspective views for describing the operation forprojecting a biosensor from the sensor pack.

FIG. 13 is an exploded perspective view of a sensor pack.

FIG. 14A-14H each is a schematic view for describing the manner ofrecognizing the information relating to the biosensor by utilizing theinformation providing portion.

FIGS. 15A and 15B each is a schematic view for describing anotherexample of information providing portion.

FIG. 16 is an entire perspective view of a biosensor.

FIG. 17 is an exploded perspective view of a biosensor.

FIG. 18A is a sectional view taken along lines Z4-Z4 in FIG. 16, whereasFIG. 18B is a sectional view taken along lines Z5-Z5 in FIG. 16.

FIG. 19 is a schematic view showing a manufacturing apparatus todescribe a method of manufacturing a sensor pack.

FIGS. 20A and 20B each is a perspective view showing a principal portionto describe a method of manufacturing a sensor pack.

FIG. 21 is a sectional view taken along lines Z6-Z6 in FIG. 19.

FIGS. 22A and 22B each is a perspective view showing a principal portionto describe a method of manufacturing a sensor pack.

FIG. 23 is a sectional view taken along lines Z7-Z7 in FIG. 19.

FIG. 24 is an entire perspective view of a measurement mechanism.

FIG. 25 is a sectional view taken along lines Z8-Z8 in FIG. 24.

FIG. 26 is a sectional view taken along lines Z9-Z9 in FIG. 25.

FIG. 27 is a front view of a slide block.

FIGS. 28A and 28B each is a sectional view of a principal portion todescribe means for holding a sensor pack in the measurement mechanism.

FIG. 29A-29C are sectional views showing a principal portion to describethe movement of a movable cutter.

FIGS. 30A and 30B are sectional views showing a principal portion todescribe the operation for projecting a biosensor from a sensor pack.

FIG. 31 is a sectional view showing a principal portion of a measurementmechanism.

FIG. 32 is a sectional view showing a principal portion to describe theoperation for discharging a sensor pack from the measurement mechanism.

FIG. 33 is a sectional view showing a slide guide of a measurementmechanism according to a second embodiment of the present invention.

FIG. 34 is a sectional view taken along lines Z10-Z10 in FIG. 33.

FIG. 35 is a sectional view taken along lines Z11-Z11 in FIG. 33.

FIG. 36 is an entire perspective view of a biosensor.

FIG. 37A is a sectional view showing a measurement mechanism in feedinga biosensor, whereas FIG. 37B is an entire perspective view showing abiosensor which is being fed.

FIG. 38A is a sectional view showing a measurement mechanism in feedinga biosensor, whereas FIG. 38B is an entire perspective view showing abiosensor which is being fed.

FIG. 39A is a sectional view showing a measurement mechanism in whichthe blade is escaping, whereas FIG. 39B is an entire perspective viewshowing a biosensor in the escaping movement.

FIG. 40A is a sectional view showing a measurement mechanism in whichthe biosensor is being returned, whereas FIG. 40B is an entireperspective view showing the biosensor in the returning movement.

FIG. 41 is an entire perspective view showing another example ofbiosensor which can be used in the second embodiment.

FIG. 42 is an exploded perspective view showing another example ofsensor pack.

FIGS. 43A and 43B are an exploded perspective view and an entireperspective view, respectively, for describing another example of sensorpack.

FIG. 44 is an entire perspective view showing another example ofbiosensor.

FIG. 45 is a perspective view showing the appearance of an example ofprior art measurement device.

FIG. 46 is a perspective view showing an example of prior art cartridgeand film for covering a sensor.

FIGS. 47A and 47B show the operation of a prior art measurement device.

BEST MODE FOR CARRYING OUT THE INVENTION

Preferred embodiments of the present invention will be described belowwith reference to the accompanying drawings.

A sensor pack according to the present invention encloses a biosensorand is used for analyzing a sample liquid such as blood supplied to thebiosensor, specifically, for measuring e.g. the glucose level in blood.In use, the sensor pack is set to an analyzer X shown in FIGS. 1 and 2.

The analyzer X comprises a device body 2 formed with an accommodationportion 20 for accommodating a sensor pack 1, and comprises a lid 3which is attached to the device body 2 in an openable and closeablemanner. The lid 3 is provided with a display 30 and a window 31. Thedisplay 30, serving to show measurement results, comprises an LCD, forexample. The window 31 is used for checking the number of remainingsensor packs 1 in the accommodation portion 20. The window 31 may beformed by covering an opening 32 provided in the lid 3 by a transparentmember 33.

As shown in FIG. 3, in addition to the accommodation portion 20, thedevice body 2 includes an opening mechanism 4, a measurement mechanism5, a passage 21 extending from the accommodation portion 20 to themeasurement mechanism 5 through a wait position (stop position at whichthe opening mechanism 4 performs the opening operation), and a feeder 22for moving the sensor pack 1 within the passage 21.

As shown in FIGS. 2 through 4, the accommodation portion 20 serves toaccommodate a plurality of sensor packs 1 as stacked. As shown in FIG.5A, the accommodation portion 20 is formed with a tapered portion 23 forpreventing improper loading of the sensor packs (loading of the sensorpacks 1 upside down or inside out). Though not clearly shown in thefigure, the tapered portion 23 extends in a direction perpendicular tothe sheet surface. On the other hand, each sensor pack 1 is formed witha tapered surface 10 provided by chamfering one of the corners.Therefore, the sensor pack 1 can be loaded properly in the accommodationportion 20 when the tapered surface 10 of the sensor pack 1 is alignedwith respect to the tapered portion 23 of the accommodation portion 20.The sensor pack 1 cannot be loaded properly without such alignment.Thus, improper loading of the sensor pack 1 is prevented. The means forpreventing the improper loading of the sensor pack 1 is not limited tothe example shown in FIG. 5. For example, as shown in FIG. 5B′, theaccommodation portion 20 may be formed with a projection 23′ while thesensor pack 1 is formed with a recess 10, or another arrangement may beemployed.

The accommodation portion 20 further accommodates a pushing member 24.The pushing member 24 is fixed to the device body 2 via a resilientmember 25 (illustrated as a coil spring in FIGS. 3 and 4). By theresilient force of the resilient member 25, the sensor pack 1 is pushedin the direction indicated by the arrow A in the figure. The sensor pack1, thus held in the pushed state, is then held at the wait position andfinally transferred to the measurement mechanism 5 by the movement ofthe feeder 22 . Preferably, the feeder 22 is moved automatically by amotor, for example. Alternatively, the device body 2 or the lid 3 may beprovided with an operation knob projecting therefrom and movabletogether with the feeder 22, so that the feeder 22 is moved manually bymoving the operation knob.

As shown in FIGS. 4A and 4B, the pushing member 24 is connected to thelid 3 via a rod 26. The rod 26 has a first end connected to the pushingmember 24 for pivotal movement and a second end connected to the lid 3via an elongated hole 34 formed in the lid 3. As shown in FIG. 4A, theelongated hole 34 extends in the direction indicated by the arrows AB inthe state in which the lid 3 is closed. Therefore, when the lid 3 isclosed, the second end of the rod 26 can move smoothly within theelongated hole 34. Accordingly, following the movement of the pushingmember 24, the rod 26 can move in the direction indicated by the arrowsAB in the figure, whereby the pushing member 24 can maintain the statefor properly pushing the sensor pack 1.

As shown in FIG. 4B, in opening or closing the lid 3, the direction inwhich the elongated hole 34 extends becomes non-parallel to thedirection indicated by the arrows AB. In this state, the second end ofthe rod 26 cannot move smoothly within the elongated hole 34. Therefore,when the lid 3 is opened, the push member 24, following the movement ofthe lid 3, moves in the direction indicated by the arrow B, whereby aspace is defined between the push member 24 and the sensor pack 1. Thespace is utilized for additionally loading a sensor pack 1 into thedevice body 2.

As shown in FIGS. 6 and 7, a plurality of sensor packs 1 for additionalloading are preferably stored as accommodated in a container 6. Theillustrated container 6 includes a container body 60 for accommodating aplurality of sensor packs 1, and a lid 61 attached to the container body60 and provided with a hook 62. The container body 60 is provided with aprojection 63 and an opening 64. The projection 63 serves to engage thehook 62. By this engagement, the state in which the lid 61 is closed ismaintained properly. As better shown in FIG. 7, the sensor packs 1accommodated in the container body 60 can be pushed up by inserting e.g.a finger into the opening 64. Thus, a required number of sensor packs 1can be taken out easily.

Preferably, in the container body 60, a plurality of sensor packs 1 arestored as stacked and bundled together. Specifically, the bundle ofsensor packs 1 is made by using an adhesive element 11 a such as adouble-sided adhesive tape or an adhesive as shown in FIG. 8A, by usinga strip 11 b as shown in FIG. 8B or by using a film 11 c having anadhesive surface as shown in FIG. 8C. The methods shown in FIGS. 8A-8Care merely examples, and the sensor packs 1 may be bundled by methodsother than those shown in the figures.

As shown in FIGS. 9 and 10, the sensor pack 1 includes a pair of sealingsheets 12 a, 12 b, and a biosensor 13 and a base film 14 which areenclosed between the sealing sheets. In using the sensor pack 1, a slit15 is formed at the front end as shown in FIGS. 11, and the biosensor 13is caused to project from the slit 15, as shown in FIG. 12B.

For example, each of the sealing sheets 12 a, 12 b may be a laminateformed by disposing an aluminum foil between resin sheets . As shown inFIG. 13, the sealing sheet 12 a has an obverse surface provided with aninformation providing portion 16 for outputting information relating tothe biosensor 13. Examples of the information relating to the biosensor13 may include data (correction information) which enables computationbased on the sensitivity of the biosensor 13, or individual informationon the biosensor 13 (the date of production, the expiry date, themanufacturer, the place of production (e.g. country or factory), and theidentification information of the lot (lot number) in which thebiosensor 13 is included. In this embodiment, the formation pattern ofthe information providing portion 16 is selected depending on thecontent of the information to be outputted. For example, as shown inFIGS. 14A-14H, the information providing portion 16 includes a commonelectrode 16 a in the form of a strip and three individual electrodes 16b. With respect to each of the individual electrodes 16 b, whether ornot the individual electrode 16 b is connected to the common electrode16 a via a conductor 16 c is selected, whereby an appropriate pattern(information) can be selected from eight patterns. The number of theindividual electrodes and the number of patterns are not limited tothose illustrated in the figures. The information providing portion 16can be provided with an intended pattern by screen printing or vapordeposition, for example. The recognition manner of the informationprovided by the informaticn providing portion 16 will be describedlater.

The information providing portion may have another structure as shown inFIGS. 15A and 15B. The information providing portion 16A shown in FIG.15A includes a pair of pads 16 d, 16 e connected to each other via aresistor 16 f. In the information providing portion 16A, the resistanceof the resistor 16 f is set depending on the content of the informationto be outputted. The resistance of the resistor 16 f is adjusted byselecting the thickness, width, length or material of the resistor 16 f.The information providing portion 16B shown in FIG. 15B can outputinformation of an intended content by selecting whether or not a cutout16 g is formed at a predetermined portion. Obviously, the informationproviding portion may have a structure different from those shown inFIGS. 13, 15A and 15B.

As shown in FIGS. 11 through 13, the base film 14 has a T-shapedthrough-hole 140. The through-hole 140 comprises an unsealing groove 141and a guide groove 142 connected to each other. As better shown in FIG.11, the unsealing groove 141 is utilized for forming the slit 15 in thefront end of the sensor pack 1. The slit 15 is formed by breaking thesensor pack 1 with a blade 41, and the unsealing groove 141 is providedto help the penetrating movement of the blade 41. The guide groove 142is utilized for causing the biosensor 13 to project from the sensor pack1. Specifically, the biosensor 13 is caused to project from the sensorpack 1 by moving the biosensor 13 by using a blade 553, and the guidegroove 142 guides the movement of the blade 553. The configuration ofthe through-hole 140 is not limited to the illustrated one. For example,part of the through-hole may be open to a side of the base film.

The base film 14 having the above configuration is bonded to one of thesealing sheets 12 a at the periphery thereof and more specifically at abonding region 143 which is cross-hatched in FIG. 13. Though notillustrated in the figure, the base film 14 is bonded also to the otherone of the sealing sheets 12 b in a similar manner.

The bonding region 143 includes a pair of extensions 144. With theprovision of the extensions 144, a space 145 accommodating the biosensor13 is defined between the sealing sheet 12 a and the base film 14. Asshown in FIGS. 9, 10A and 10B, the width of the space 145 is narrow at aportion corresponding to the extensions 144. The narrow portion servesas a stopper portion 146 for stopping the movement of the biosensor 13,as will be described later.

The provision of the stopper portion 146 eliminates the need forproviding a stopper mechanism for stopping the movement of the biosensor13 in the analyzer X, whereby the analyzer X is advantageous in terms ofthe manufacturing cost. Further, the handling of the biosensor 13 formeasurement or disposal, for example, can be performed while keeping thebiosensor 13 integral with the pack. Moreover, the biosensor 13 afteruse can be easily accommodated again just by pushing the biosensor 13into the sensor pack 1.

Since the space 145 accommodates the biosensor 13, it is preferable tokeep the humidity in the space 145 low. The base film 14 can be made ofa resin material such as polyethylene, polyethylene terephthalate orpolyamide. Therefore, desiccant powder such as silica or molecular sievemay be contained in the base film 14 to provide dehumidifying function.In this case, the content of the desiccant powder is preferably 1 to 60%by weight, and more preferably 20 to 40% by weight relative to the totalweight of the base film 14. The desiccant powder may be contained orapplied to the sealing sheet 12 a, or the biosensor 13 itself may havedehumidifying function.

The containing or the like of the desiccant powder eliminates the needfor loading a desiccant in the space 145 and provides an advantage interms of the manufacturing cost. Since dropping of the desiccant fromthe space 145 does not occur in opening the sensor pack 1, troubles dueto the dropped desiccant can be avoided.

As shown in FIGS. 13, 16 and 17, the biosensor 13 has a rounded frontend, and a rear end provided with a cutout 130 and a stopper portion131. As better shown in FIGS. 12A and 12B, the cutout 130 serves toallow the penetration of the blade 553 through the sensor pack 1 and thepushing of the biosensor 13 by the blade 553. The stopper portion 131 ofthe biosensor 13 engages the stopper portion 146 of the sensor pack 1when the biosensor 1 has moved to stop the movement of the biosensor 13.As shown in FIGS. 16 and 17, the biosensor 13 comprises a substrate 132,and a spacer 18 and a cover 19 which are stacked on the substrate. Asshown in FIG. 18A, a flow path 133 is defined on the substrate 132.

As shown in FIGS. 17 and 18A, the spacer 18 is formed with a narrow slit180 having an open end, and the slit 180 defines the flow path 133. Thecover 19 is formed with a hole 190 communicating with the slit 180 sothat gas in the flow path 133 can be discharged to the outside throughthe hole 190. Therefore, when a sample liquid is supplied through thefront open end (sample introduction port) 181 of the slit 180, thesample liquid travels through the flow path 133 toward the hole 190 bycapillary action.

As shown in FIGS. 16 and 17, on the substrate 132 are provided anoperative electrode 134, a counterpart electrode 135, a pair ofdetection electrodes 136, and a reagent layer 137 continuously bridgingthe electrodes 134-136. As shown in FIG. 18B, each of the electrodes134-136 is partially exposed via through-holes 138 penetrating throughboth of the spacer 18 and the cover 19. With this arrangement, probes591-594, which will be described later, can be brought into contact withthe electrodes 134-136 through the through-holes 138, whereby theapplication of a voltage to the reagent layer 137 and the measurement ofthe responsive current when the voltage is applied can be performed.

The reagent layer 137, which may be solid, is prepared by dispersing arelatively small amount of oxidoreductase in a relatively large amountof mediator (electron carrier), for example.

As the electron carrier, use may be made of iron complex or Ru complex,for example. In this case, examples of usable iron complex includepotassium ferricyanide, whereas examples of usable Ru complex includeone having NH₃ as a ligand.

The selection of the oxidoreductase depends on the kind of theparticular component as the measurement target substance. Examples ofparticular component include glucose, cholesterol and lactic acid.Examples of oxidoreductase for such particular components includeglucose dehydrogenase, glucose oxidase, hexokinase, cholesteroldehydrogenase, cholesterol oxidase, lactic acid dehydrogenase and lacticacid oxidase.

For example, the above-described sensor pack 1 can be manufactured bythe method which will be described below with reference to FIGS. 19-23.Herein, it is assumed that the biosensor 13 to be accommodated in thesensor pack 1 is manufactured in advance, and the description of themanufacturing method is omitted.

As shown in FIG. 19, the sensor pack 1 is formed by placing thebiosensor 13 at an appropriate position on a punch film 70, bondingsealing films 71 and 72, and then cutting the bonded member.

Specifically, as shown in FIG. 20A, a plurality of base film formingregions 700 are defined on the punch film 70. Each of the base filmforming regions 700 is formed with a generally T-shaped through hole701. Each of the base film forming regions 700 is supported relative toa flame portion 702 and/or an adjacent base film forming region 700 viaa support bar 703. As shown in FIG. 19, the punch film 70 is transferredby a belt conveyor 8. The belt 8A of the belt conveyor 8 is made porousor in the form of a mesh to have excellent breathability.

As shown in FIGS. 19 and 21, the placing of the biosensor 13 on thepunch film 70 is performed automatically by using a vacuum collet 80,for example. As will be understood from e.g. FIGS. 20B and 21, theplacing operation is performed individually with respect to each of thebase film forming region 700. Alternatively, a plurality of biosensors13 may be placed simultaneously. The biosensors 13 thus placed are keptat respective positions by a plurality of suction nozzles 81 providedbelow the punch film 70. Specifically, since the through-hole 701 isformed in each of the base film forming regions 700 and the belt 8A hasexcellent breathability, when each of the suction nozzles 81 is placeddirectly below the biosensor 13 to suck the biosensor, the biosensor 13is pulled toward the suction nozzle 81 while being kept in close contactwith the base film forming region 700.

The suction nozzles 81 are movable together with the punch film 70 inthe direction indicated by arrows CD in FIG. 19. Therefore, each of thebiosensors 13 is transferred together with the punch film 70 while beingpositioned at the base film forming region 700. The positioned state ismaintained until the subsequent step for bonding the sealing film 71 iscompleted.

The bonding of the sealing film 71 is performed by laying the sealingfilm 71 on the punch film 70 as an overlying layer as shown in FIG. 22A,and then applying thermal energy by using a plurality of (three in thefigure) fusing stamps 82 as shown in FIGS. 19 and 23. The sealing film71 is supplied from the roll 78. The sealing film 71 is formed, inadvance, with information providing portions (indicated by referencesign 16 in FIG. 13) at portions corresponding to the base film formingportions 700. The information providing portions may be formed after thesealing film 71 is bonded.

The fusing stamps 82, which are spaced in the widthwise direction of thebelt conveyor 8, fuse the sealing film 71 to a plurality of base formingregions 700 simultaneously. Each of the fusing stamps 82 has an endsurface having a configuration corresponding to the hatched portion 85in FIG. 22B so that thermal energy can be applied selectively to theperipheral portion of each of the base film forming regions 700. Each ofthe fusing stamps 82 is individually movable up and down by the drivingforce of a non-illustrated pump, for example. Therefore, even when theregions (fusion portions) to which the fusing stamps 82 are to applythermal energy differ from each other in height, such a problem can beproperly addressed, and proper bonding can be achieved. Specifically, asa result of the individual driving of the fusing stamps 82, each of thefusing stamps 82 can be located at its own height position. Therefore,even when the fusion portions have height variation, each of the fusionstamps 82 can be located at a position corresponding to the higherfusion portion. Thus, thermal energy can be properly applied to eachfusion portion, whereby thermal fusing can be properly performed.

After the thermal fusing, the biosensor 13 is retained at an appropriateposition between the punch film 70 and the sealing film 71. The suctionof the biosensor 13 by using the suction nozzle 81 is released.

Subsequently, after the sealing film 71 is cut, the sealing film 71 andthe punch film 70 are turned over and transferred onto a belt conveyor8′ for bonding a sealing film 72 (See FIG. 19). With the sealing film 72placed on the punch film 70 as an overlying layer, the sealing film 72is bonded. As a result, the biosensor is hermetically sealed between thepaired sealing films 71 and 72. The bonding of the sealing film 72 isperformed by using fusing stamps 82′ which are similar to thosedescribed above. Thereafter, cutting is performed at a portioncorresponding to each of the film forming regions 700, wherebyindividual sensor packs 1 as shown in FIGS. 9 and 13 are obtained.

Each of the sealing films 71, 72 is not limited to one in the form of ahoop, and use may be made of one which has been cut to a sizecorresponding to the size of the punch film 70. The bonding of thesealing film 72 may be performed by placing the sealing film 72 on thebelt conveyor 8′ in advance, placing the sealing film 71 and the punchfilm 70 on the sealing film 72 without turning over, and then performingfusing.

The opening mechanism 4 shown in FIG. 3 serves to open the sensor pack 1held at the wait position. The blade 41 and an operation button 40 areincluded in the opening mechanism 4. The operation button 40 isaccommodated in a space 27 defined in the device body 2 while beingbiased toward the front side of the device body 2 (in the directionindicated by the arrow A in the figure) by a resilient member 42(illustrated as a coil spring in FIG. 3). The blade 41 is integrallyformed on the operation button 40 to move together with the operationbutton 40. Therefore, when a pushing force to push the operation button40 toward the deeper side of the device body (in the direction indicatedby the arrow B in the figure) is applied to the button, the blade 41moves together with the operation button 40 in the arrow B direction topenetrate through the front end of the sensor pack 1, as shown in FIG.11A. Accompanying the pushing of the operation button 40, a power sourcefor driving the measurement mechanism 5, for example, may be turned onor the feeder 22 shown in FIG. 3 may be moved to automatically feed asensor pack 1 toward the measurement mechanism 5. When the force exertedto the operation button 40 is released, the operation button 40 and theblade 41 return to their original positions. Thus, the slit 15 as shownin FIG. 11B is formed at the front end of the sensor pack 1, whereby thesensor pack 1 is opened. Although the blade 91 moves integrally with theoperation button 40 in the illustrated example, the blade may be soarranged as to move following the movement of the operation button. Inthis case, the following movement may be realized by a mechanical systemor an electrical system.

At the wait position, information relating to the biosensor 13 is readby utilizing the information providing portion 16 before the sensor pack1 is opened. Specifically, as will be understood from FIGS. 14A-14H, thedevice body 2 is provided with a single common terminal 43 and threeindividual terminals 44. When the sensor pack 1 is at the wait position,the common terminal 43 comes into contact with the common electrode 16 aof the sensor pack 1, whereas the tree individual terminals 44 come intocontact with respective individual electrodes 16 b of the sensor pack 1.The information of the information providing portion 16 is recognizedbased on the presence or absence of conduction between each of theindividual terminals 44 and the common terminal 43 as well as thecombination thereof. As will be understood from FIGS. 14A-14H, eightkinds of information distinguishable from each other can be recognizedin this embodiment. When the information providing portion 16A as shownin FIG. 15A is utilized, a single measurement terminal 44A is providedin the device body 2 (See FIGS. 2 and 3). When the information providingportion 16B as shown in FIG. 15B is utilized, a plurality of switches 45and a plurality of movablemembers 46 capable of individually opening andclosing the switches 45 are provided in the device body. In this case,each switch 45 is kept open when the relevant movable member 46 isreceived in a cutout 16 g of the sensor pack 1, whereas the switch 45 isclosed when the movable member 46 is located at a portion which is notformed with a cutout 16 g. The information of the information providingportion 16B is recognized based on the combination of ON/OF of eachswitch 45.

For example, when the sensor pack 1 is provided with information on thelot and the usable period, the device may automatically performcorrection so as not to perform the measurement when the usable periodof the sensor pack 1 is expired. With such an arrangement, when a useradditionally loads sensor packs 1 into the accommodation portion (SeeFIGS. 2 and 3), the user need not pay attention to the lot and usableperiod of each sensor pack 1 to be loaded, which is convenient.

The measurement mechanism 5 serves to cause the biosensor 13 to projectfrom the sensor pack 1 opened and transferred from the wait position andto measure the concentration of a particular component in the sampleliquid supplied to the biosensor 13. As shown in FIG. 24, themeasurement mechanism 5 includes a base 50, and a slider 51 slidablyconnected to the base. The slider 51 is reciprocally movable by knownmeans such as a rack and pinion mechanism by utilizing the driving forceof e.g. a motor (not shown).

As shown in FIGS. 24-26, the base 50 includes a base portion 52 and sidewalls 53 extending upward from opposite side edges of the base portion52. The base 50 further includes opposite ends provided with plateframes 501, 502. The plate frame 501 is formed with an opening 503 forintroducing the sensor pack 1, whereas the plate frame 502 is formedwith an opening 504 for discharging the sensor pack 1. The plate frames501, 502 support a guide rod 505.

The base portion 52 has an upper surface formed with two guide grooves520 and is formed with a space 54 at the center portion thereof, asshown in FIG. 25. A movable cutter 55 is arranged in the space 54, andan elongated hole 541 is formed at a side wall 540 defining the space54. The movable cutter 55 comprises a blade 553 and a holding block 552for holding the blade. The movable cutter 55 has opposite ends one ofwhich is pivotally connected to the base 50 via a shaft portion 550. Theother end of the movable cutter 55 is connected to the elongated hole541 via a shaft portion 554, so that the pivoting range of the movablecutter 55 is defined by the elongated hole 541. Each of the side walls53 has an upper portion formed with an elongated hole 530, and an uppersurface 531 formed with a tapered portion 532 at an end thereof.

The slider 51 includes a slide guide 56 and a slider block 57. Theslider guide 56 and the slider block 57 are connected to each other viaa resilient member 510 (illustrated as a coil spring in the figure) andpins 511. Therefore, the slide guide 56 and the slider block 57 can movetogether relative to the base 50 and move vertically relative to eachother.

As shown in FIGS. 24-27, the slider block 57 is provided with a pair offront hooks 570 and a pair of rear hooks 571. As better shown in FIG.27, the front hooks 570 and the rear hooks 571 serve to hold the sensorpack 1 and are so arranged that the distance between the front hooks 570and the rear hooks 571 corresponds to the length of the sensor pack 1.Though not clearly shown in the figure, the distance between the pairedfront hooks 570 and the distance between the paired rear hooks 571 areset to be smaller than the width of the sensor pack 1 and larger thanthe width of the biosensor 13.

Each of the front hooks 570 is formed integrally on the slider block 57.However, the front hook may be made separately from the slider block.Each of the rear hooks 571 is connected to the rear end of the sliderblock 57 via a shaft 572. The rear hook 571 is pivotally supported bythe slider block 57 while being biased downward by a resilient member573. The rear end of the rear hook 571 has a curved surface.

As noted above, the sensor pack 1 is transferred to the measurementmechanism 5 by the feeder 22. Specifically, as shown in FIG. 28A, thesensor pack 1 is transferred onto the base portion 52 of the base 50through the opening 503 of the plate frame 501. When the sensor pack 1is further pushed from this position, the sensor pack 1 moves whilecoming into contact with the curved surface of the rear hooks 571,whereby the rear hooks 571 are lifted. As shown in FIG. 28B, when thesensor pack 1 is moved until the front end of the senor pack 1 engagesthe front hooks 570, the front hooks 570 hinder further advancement ofthe sensor pack 1. Since the distance between the front hooks 570 andthe rear hooks 571 corresponds to the length of the sensor pack 1, therear end of the sensor pack 1 engages the rear hooks 571, whereby thesensor pack 1 is snugly held between the front hooks 570 and the rearhooks 571. In this state, the sensor pack 1 is movable together with theslider block 57, and hence, with the slider 51.

As shown in FIGS. 24-26, the slider guide 56 includes an upper frameportion 560, and side walls 561 extending downward from opposite sideedges of the upper frame portion 560. The upper frame portion 560 isformed with a through-hole 562. The guide rod 505 is inserted in thethrough-hole 562, whereby the upper frame portion 560, and hence, theslide guide 56 is supported by the guide rod 505. With this arrangement,the slide guide 56, and hence the entirety of the slider 51 is movablealong the guide rod 505.

The side wall 561 is formed with a cam groove 563. The cam groove 563has opposite ends respectively provided with a first and a secondstraight movement portions 564 and 565 which differ from each other inheight position. The straight movement portions 564 and 565 areconnected to each other via an up/down movement portion 566. The camgroove 563 receives the shaft portion 554 of the movable cutter 55.Therefore, when the position of the shaft portion 554 in the cam groove563 is changed by moving the slide guide 56, the movable cutter 55pivots, whereby the height position of the blade 553 of the movablecutter 55 changes.

Specifically, as shown in FIGS. 28B and 29A, when the slider 51 ispositioned on the right side in the figure and the shaft portion 554 ispositioned in the first straight movement portion 564, the blade 553 ofthe movable cutter 55 is positioned at the bottom dead center. As shownin FIG. 29B, when the slide guide 56 is moved to move the shaft portion554 from the first straight movement portion 564 toward the secondstraight movement portion 565 through the up/down movement portion 566,the blade 553 of the movable cutter 55 moves upward. As shown in FIG.29C, when the shaft portion 554 reaches the second straight movementportion 565, the blade 553 is positioned at the top dead center.

As shown in FIG. 12A, the blade 553 moved upward in the above mannerpenetrates through the sensor pack 1. The blade 553 then engages thecutout 130 of the biosensor 13. In this state, when the slider 51 ismoved relative to the base 50 in the direction indicated by the arrow Ein the figures (See FIGS. 29A-29C), the sensor pack 1 moves togetherwith the slider 51 in the arrow E direction, because the sensor pack 1is held by the front hooks 570 and the rear hooks 571, as shown in FIG.30. During this movement, the shaft portion 554 is positioned in thesecond straight movement portion 565, so that the blade 553 of themovable cutter 55 is kept at the top dead center. As a result, theengagement of the blade 553 with the biosensor 13 is maintained, so thatthe biosensor 13 moves relative to the sensor pack 1 (relative to thesealing sheets 12 a, 12 b and the base film 14, to be exact) in thedirection indicated by the arrow F.

As a result, as shown in FIG. 12B, the biosensor 13 projects through theslit 15 previously formed in the sensor pack 1. Since the distancebetween the paired front hooks 570 is larger than the width of thebiosensor 13, the biosensor 13 projects from between the front hooks570. Since the front end of the biosensor 13 is rounded, the projectingoperation can be performed smoothly. The movement of the biosensor 13 isstopped when the stopper portion 131 of the biosensor 13 engages thestopper portion 146 of the sensor pack 1. Thus, the plurality ofthrough-holes 138, and hence, the electrodes 134-136 of the biosensor 13are exposed to the outside. In this embodiment, the exposed area of eachelectrode 134-136 is made as small as possible by the provision of thethrough-holes 138. Therefore, the electrodes 134-136 of the biosensor 13projecting from the slit are prevented from coming into contact with thenearby portion of the slit 15 of the sealing sheet 12 a, whereby shortcircuiting between the electrodes 134-136 are prevented.

As shown in FIG. 30B, when the slide guide 56 is moved in the arrow Fdirection in the figure, the shaft portion 554 moves from the secondstraight movement portion 565 toward the first straight movement portion564 through the up/down movement portion 566, whereby the blade 553 ofthe movable cutter 55 moves downward. At this time, the entirety of thesensor pack 1 including the biosensor 13 moves in the arrow F direction,so that the biosensor 13 projects from the measurement mechanism 5, andhence, from an opening 29 of the device body 2 shown in FIGS. 1 and 2.As will be understood from FIG. 18A, to the biosensor 13 in this state,the sample liquid is supplied through the sample introduction port 181for performing analysis of the sample liquid.

As shown in FIG. 31, four probes 591-594 are fixed to the slider block57. As shown in FIG. 18B, the probes 591-594 are so arranged as to comeinto contact with the electrodes 134-136, respectively, through thethrough-holes 138 when the biosensor 13 is in the state shown in FIG.12B. With this arrangement, a voltage can be applied to the reagentlayer 137 shown in FIGS. 17 and 18A, and the responsive current can bemeasured. Based on the responsive current, analysis of the sample (e.g.computation of the concentration of a particular component in the sampleliquid) can be performed, or the introduction of the sample liquid intothe flow path 133 can be detected.

As shown in FIGS. 24 and 27, the upper end of the slider block 57 isformed with a pair of flanges 59 projecting widthwise outward of theslider block 57. Each of the flanges 59 slides on the upper surface 531of the corresponding side wall 53 of the base 50 when the slider block57 (slider 51) moves relative to the base 50. As noted above, a taperedportion 532 is formed at an end of the upper surface 531. Therefore, asshown in FIGS. 27 and 32, when the flange 59 rides on the taperedportion, the end of the slider block 57 (slider 51) is lifted relativeto the base 50. As a result, the engagement between the front hooks 570and the sensor pack 1 is released, whereby the sensor pack 1 togetherwith the biosensor 13 is released from the measurement mechanism 5, orfrom the opening 29 (See FIGS. 1 and 2) of the device body 2. In theanalyzer X, the entirety of the biosensor 13 may be accommodated againin the sensor pack 1 before the disposal of the sensor pack 1. In thiscase, the user can dispose of the biosensor without touching thebiosensor 1 (particularly blood), which is preferable from a hygienicpoint of view.

As described above, since the front end of the biosensor need not bemade sharp, the user does not feel fear and is not hurt by the biosensor13. The sensor pack 1 after the analysis can be disposed of togetherwith and at the same time as the biosensor 13. Therefore, the number ofparts to be disposed of is small, and the sensor pack 1 can be disposedof with little trouble.

Next, a second embodiment of the present invention will be describedbelow with reference to FIGS. 33-40. In FIGS. 33-40, elements which areidentical or similar to those of the first embodiment described aboveare designated by the same reference signs, and the description thereofis omitted below.

As shown in FIG. 33, the slide guide 56C of the measurement mechanism ofthe analyzer includes a side wall 561C formed with a non-penetrating camgroove 563C. The cam grove 563C includes an upper groove portion 567AC,a lower groove portion 567BC, a downward movement groove portion 568Cconnecting between the groove portions 567AC and 567BC, and an upwardmovement groove portion 569C.

The upper groove portion 567AC includes a first and a second straightmovement portions 564C and 565C which differ from each other in heightposition, and an up/down movement portion 566C connecting between thestraight movement portions 564C and 565C. As will be understood fromFIGS. 33-35, the first and the second straight movement portions 564C,565C and the up/down movement portion 566C have the same depth.

The lower groove portion 567BC extends below the first and the secondstraight movement portions 564C, 565C and in parallel with the first andthe second straight movement portions 569C, 565C. The lower grooveportion 567BC has a uniform depth which is generally equal to that ofthe upper groove portion 567AC.

The downward movement portion 568C connects an end of the upper grooveportion 567AC and an end of the lower groove portion 567BC to eachother, and the part of the downward movement portion connected to theend of the lower groove portion 567BC is smaller in depth than the lowergroove portion 567BC, as better shown in FIG. 34.

As shown in FIG. 33, the upward movement portion 569C connects the uppergroove portion 567AC and the lower groove portion 567BC to each other ata position deviated from the downward movement portion 568C in the arrowE direction. As better shown in FIG. 35, the part of the upward movementportion 569C connected to the upper groove portion 567AC is smaller indepth than the upper groove portion 567AC.

As will be understood from e.g. FIG. 37A, the cam groove 563C receivesthe shaft portion 554 of the movable cutter 55. Therefore, by moving theslide guide 56C, the position of the shaft portion 554 in the cam groove563C changes. As a result, the movable cutter 55 pivots so that theheight position of the movable cutter 55 changes. In the cam groove 563Chaving the above configuration, it is preferable that the shaft portion554 is biased toward the side wall 561C.

In this embodiment, a biosensor 13C as shown in FIG. 36 is used, forexample. The illustrated biosensor 13C is similar in basic structure tothe biosensor 13 (See FIG. 16) used in the first embodiment but differsfrom the biosensor 13 in structure for engagement with the blade 553 ofthe movable cutter 55. Specifically, the portion for engagement with theblade 553 comprises a through-hole 130C.

In this embodiment, the slide guide 56C is caused to reciprocate twicein the arrow EF direction in the figure in a single sample analysisoperation (See FIG. 33). Specifically, the first reciprocal movement isperformed to cause the biosensor 13 to project from the slit 15 of thesensor pack 1C similarly to the first embodiment (See FIG. 38B), whereasthe second reciprocal movement is performed to pull the biosensor 13Cinto the sensor pack 1C to accommodate the biosensor 13C again (See FIG.40B).

As shown in FIG. 33, the movement route of the shaft portion 554 (Seee.g. FIG. 37A) of the movable cutter 55 in the cam groove 563C differsbetween the first reciprocal movement (for pushing out the biosensor 13C(See FIG. 38B)) and the second reciprocal movement (for accommodatingthe biosensor 13C again (See FIG. 40B)). Thus, the blade 553 of themovable cutter 55 operates differently between the first reciprocalmovement and the second reciprocal movement. In FIG. 33, the movementroute of the shaft portion 554 in the first reciprocal movement isindicated by a single dashed line, whereas the movement route of theshaft portion 554 in the second reciprocal movement is indicated by achain line.

In the first reciprocal movement, the shaft portion 554 (See e.g. FIG.37A) starts from the point P1 and pass through the points P2-P5 beforereaching the point P6.

Specifically, when the slide guide 56C moves in the arrow E direction,the shaft portion 554 moves through the first straight movement portion564C, the up/down movement portion 566C, and the second straightmovement portion 565C, similarly to the first embodiment. It is to benoted that, when the shaft portion 554 reaches the point P8, the shaftportion does not enter the upward movement portion 569C but movesstraight in the arrow F direction to reach the point P4, because thesecond straight movement portion 565C is larger in depth than the partof the upward movement portion 569C connected to the second straightmovement portion 565C.

As will be understood from FIG. 37A, when the shaft portion 554 ispositioned in the first straight movement portion 564C (between thepoints P1 and P2), the blade 553 of the movable cutter 55 is located ata first bottom dead center. When the slide guide 56C is moved in thearrow E direction to move the shaft portion 554 from the first straightmovement portion 564C toward the second straight movement portion 565Cthrough the up/down movement portion 566C (between the points P2 andP3), the blade 553 of the movable cutter 55 moves upward. When the shaftportion 554 reaches the second straight movement portion 565C (pointP3), the blade 553 is positioned at the top dead center.

As shown in FIG. 37B, the blade 553 moved upward in the above mannerpenetrates through the sensor pack 1C and is inserted into thethrough-hole 130C of the biosensor 13C for engagement with the innersurface of the through-hole 130C. In this state, when the slider 51 ismoved relative to the base 50 in the direction indicated by the arrow Ein the figures, the sensor pack 1C moves together with the slider 51 inthe arrow E direction, as shown in FIGS. 38A and 38B. During thismovement, the shaft portion 554 is positioned in the second straightmovement portion 565C, so that the blade 553 is kept at the top deadcenter. As a result, as better shown in FIG. 38B, the engagement of theblade 553 with the through-hole 130C of the biosensor 13C is maintained,so that the biosensor 13 moves relative to the sensor pack 1 (relativeto the sealing sheets 12 a, 12 b and the base film 14, to be exact) inthe direction indicated by the arrow F. As a result, the biosensor 13Cprojects from the slit 15 of the sensor pack 1C.

With the biosensor 13C projecting from the sensor pack 1C, a sample issupplied to the biosensor 13C, whereby the concentration of a particularcomponent in the sample is computed, similarly to the above-describedfirst embodiment.

Unlike the first embodiment, when the slide guide 56C moves in the arrowF direction, the shaft portion 554 moves through the downward movementportion 568C (between the points P4 and P5) to move to a lower positionand then moves straight through the lower groove portion 567BC (betweenthe points P5 and P6) to reach the point P6, as will be understood fromFIG. 33.

As can be seen from FIGS. 38A and 39A, when the slide guide 56C movesthrough the downward movement portion 568C (between the points P4 and P5in FIG. 33) , the blade 553 of the movable cutter 55 moves downward.When the shaft portion 554 reaches the lower groove portion 567BC (thepoint P5 in FIG. 33), the blade 553 is positioned at a second bottomdead center.

By moving the blade 553 downward in the above manner, the blade 553 ispulled out from the sensor pack 1C, as shown in FIGS. 39A and 39B. Inthis state, when the slide guide 56C is moved in the arrow F directionin the figure, the shaft portion 541 moves straight through the lowergroove portion 567BC (between the points P5 and P6 in FIG. 33) whilekeeping the blade 553 at the bottom dead center.

In the second reciprocal movement, the shaft portion 554 (See e.g. FIG.37A) starts from the point P6 and pass through the points P7, P8 and P2to reach the point P1, as shown in FIG. 33.

Specifically, when the slide guide 56C moves in the arrow E direction,the shaft portion 554 moves straight through the lower groove portion567BC from the point P6 toward the point P7, and then moves through theupward movement portion 569C (P7, P8) to reach the point P8. It is to benoted that, when the shaft portion 554 reaches the point P7, the shaftportion does not enter the downward movement portion 568C but movesthrough the upward movement portion 569C, because the upward movementportion 569C is larger in depth than the part of the downward movementportion 568C connected to the lower groove portion 567BC (See FIG. 34).

As will be understood from FIGS. 33 and 39A, when the shaft portion 554is located in the lower grove portion 567BC (between the points P6 andP7), the blade 553 of the movable cutter 55 is located at the secondbottom dead center. When the shaft portion 554 moves through the upwardmovement portion 569C (between the points P7 and P8), the blade 553 ofthe movable cutter 55 moves upward. When the shaft portion 554 reachesthe second straight movement portion 565C (the point P8) , the blade 553is positioned at the top dead center.

The blade 553 moved upward in the above manner is inserted again intothe through-hole 130C of the biosensor 13C for engagement with the innersurface of the through-hole 130C (See FIG. 38B). In this state, when theslider 51 is moved relative to the base 50 in the direction indicated bythe arrow F in the figures, the sensor pack 1C moves together with theslider 51 in the arrow F direction. During this movement, the shaftportion 541 is positioned in the second straight movement portion 565C,so that the blade 553 is kept at the top dead center. As a result, asbetter shown in FIG. 40B, the engagement of the blade 553 with thethrough-hole 130C of the biosensor 13C is maintained, so that thebiosensor 13C moves relative to the sensor pack 1C (relative to thesealing sheets 12 a, 12 b and the base film 14, to be exact) in thedirection indicated by the arrow E. As a result, the biosensor 13C isaccommodated again in the sensor pack 1C.

Similarly to the first embodiment, when the slide guide 56C moves in thearrow F direction, the shaft portion 554 moves through the secondstraight movement portion 565C, the up/down movement portion 566C andthe first straight movement portion 564C. In this process, the blade 553of the movable cutter 55 moves from the top dead center to the firstbottom dead center. Thus, the blade 553 is pulled out from the sensorpack 1C to become a state similar to that shown in FIG. 39B.

After the biosensor 1C is accommodated again, the slider 51 is movedrelative to the base 50 in the arrow E direction in the figure, wherebythe sensor pack 1C is disposed of in a manner similar to that in thefirst embodiment.

In this embodiment, the sensor pack 1C after use is disposed of with thebiosensor 1C accommodated in the sensor pack. Therefore, the biosensor13C can be disposed of integrally with the wrapping member, whichreduces the number of parts to be disposed of and which is preferablefrom a hygienic point of view.

As the biosensor for providing the sensor pack, use may be made of abiosensor 13D shown in FIG. 41. In the biosensor 13D, the portion forengagement with the blade 553D of the movable cutter in moving thebiosensor 13 is provided at opposite sides of the biosensor 13D.Specifically, the biosensor 13D has opposite side edges each of which isprovided with a pair of projections 130D, 131D. A blade 553D is insertedbetween the projections 130D and 131D for engagement with theprojections 130D, 131D.

The projection 130D serves to engage with the blade 553D when thebiosensor 13D is moved in the arrow F direction, and also serve as astopper for preventing the movement of the biosensor 13D relative to thesealing sheets or the base film of the sensor pack. The projection 131Dserves to engage with the blade 553D when the biosensor 13D is moved inthe arrow F direction.

When the biosensor 13D is utilized, two blades 553 need be provided inthe measurement mechanism.

The present invention is not limited to the first and the secondembodiments described above, and may be modified in various ways. Forexample, the sensor pack and the biosensor may have structures as shownin FIGS. 42-44.

The sensor pack 1 shown in FIG. 42 includes a base film 14, a sealingsheet 12 b, a biosensor 13 and a sealing sheet 12 a which are stacked inthe mentioned order.

The sensor pack shown in FIGS. 43A and 43B does not include a base film,and the biosensor is enclosed only by the sealing sheets 12 a, 12 b.

In the biosensor 13 shown in FIG. 44, the electrodes 134-136 are exposedcontinuously.

The opening mechanism of the first embodiment can be used not only foropening the sensor pack in the analyzer but also for various purposes.For example, when a wrapping member contains an object in a solid stateother than a biosensor or an object in a liquid or gel state, theopening mechanism can be used for opening the wrapping member to takeout the content. The content may be taken out by a method similar tothat of the above analyzer when the content is in a solid state.Alternatively, the content may be taken out by squeezing out with theuse of a roller, regardless of the state of the content.

1-19. (canceled)
 20. An analytical tool accommodated in a wrappingmember for providing an analytical tool pack and caused to project fromthe wrapping member in use, the analytical tool pack being made so thatthe analytical tool is moved by a pushing member relative to thewrapping member, wherein the analytical tool includes an engagementportion with which the pushing member is engaged.
 21. An analytical toolaccommodated in a wrapping member for providing an analytical tool packand including an end which is caused to project from the wrapping memberin use of the analytical tool, wherein the end is entirely rounded. 22.A cartridge including a container accommodating a plurality ofanalytical tool packs, each of the analytical tool packs including awrapping member in which an analytical tool is accommodated, wherein thecontainer is formed with a through-hole communicating with an inside ofthe container and utilized for pushing out the analytical tool packaccommodated in the container.
 23. The cartridge according to claim 22,wherein the plurality of analytical tool packs are bundled and retainedin the container.
 24. A method of making an analytical tool packcomprising the steps of placing an analytical tool on a punch film or asealing film, and bonding the sealing film to the punch film, whereinthe analytical tool is kept at an appropriate position relative to thepunch film at least for a time period from when the placing step iscompleted and till when the bonding step is started.
 25. The method ofmaking the analytical tool pack according to claim 24, wherein theposition keeping is performed by using a suction unit.
 26. A method ofmaking an analytical tool pack comprising fixing an analytical tool to asealing film or a punch film, wherein the fixing step is performedsimultaneously with respect to a plurality of analytical tools by usinga plurality of pressing heads; and wherein the pressing heads arecapable of setting respective heights individually.
 27. An analyzer foranalyzing a sample by using an analytical tool pack including a wrappingmember and an analytical tool accommodated in the wrapping member, theanalysis being performed with the analytical tool caused to project fromthe wrapping member; wherein the analyzer comprises an opening mechanismfor making a cut in the wrapping member, and a pushing mechanism formoving the analytical tool relative to the wrapping member to cause theanalytical tool to project through the cut.
 28. The analyzer accordingto claim 27, wherein, with the analytical tool caused to project fromthe wrapping member, the analyzer obtains output relating to analysisresults from the analytical tool.
 29. The analyzer according to claim27, wherein the pushing mechanism comprises a first and a second memberswhich are movable relative to each other in a first direction, and apushing member which is movable in a second direction crossing the firstdirection in accordance with the relative movement between the first andthe second members, the pushing member serving to move the analyticaltool relative to the wrapping member.
 30. The analyzer according toclaim 29, wherein the pushing member is pivotally fixed to the firstmember while being connected to the second member for relative movementto the second member, and wherein the second member is provided with aguide for moving a portion connected to the pushing member in the seconddirection.
 31. The analyzer according to claim 29, wherein the pushingmember comprises a blade.
 32. The analyzer according to claim 29,wherein the pushing mechanism further comprises a holder for moving thewrapping member together with the first member or the second member. 33.The analyzer according to claim 32, wherein the pushing mechanismfurther comprises a releaser for releasing the holding of the analyticaltool by the holder.
 34. The analyzer according to claim 33, wherein thereleaser increases a distance between the first member and the secondmember in the second direction when a particular positional relationshipis established between the first member and the second member.
 35. Theanalyzer according to claim 27, further comprising a restorer forrestoring the analytical tool projected from the wrapping member intothe wrapping member for accommodation again.
 36. The analyzer accordingto claim 29, further comprising a restorer for restoring the analyticaltool projected from the wrapping member into the wrapping member forreaccommodation, wherein the restorer is provided by the pushing member.37. The analyzer according to claim 36, wherein the second memberperforms reciprocating movement between a first predetermined positionand a second predetermined position relative to the first member twicein a single sample analysis operation, wherein the pushing memberengages with and moves the analytical tool to cause the analytical toolto project from the wrapping member when the second member moves fromthe first position toward the second position in the first reciprocatingmovement, and wherein the pushing member engages with and moves theanalytical tool to restore the analytical tool into the wrapping memberwhen the second member moves from the second position toward the firstposition in the second reciprocating movement.
 38. The analyzeraccording to claim 37, wherein the second member is provided with a camgroove for controlling operation of the pushing member, and wherein thecam groove has a configuration causing the pushing member to operatedifferently during the first reciprocating movement and during thesecond reciprocating movement.
 39. The analyzer according to claim 29,wherein the wrapping member comprises a sealing sheet, and a base filmformed with a through-hole and bonded to the sealing sheet, and whereinthe opening mechanism includes a cutter for making a cut in the wrappingmember, and wherein the cutter and the pushing member move through thethrough-hole.
 40. The analyzer according to claim 27, wherein theopening mechanism includes an operation button, and a cutter which movestogether with the operation button.
 41. The analyzer according to claim27, further comprising an accommodation portion into which theanalytical tool pack is to be loaded, wherein the accommodation portionincludes a pack orientation checker for preventing improper loading ofthe analytical tool pack into the accommodation portion.
 42. Theanalyzer according to claim 27, wherein the analyzer comprises a devicebody including an accommodation portion for accommodating a plurality ofanalytical tool packs, and a lid connected to the device body; whereinthe analytical tool packs are accommodated while being pressed againsteach other by a pressing member; and wherein the lid is connected to thepressing member to release the pressing of the analytical tool packs inopening the accommodation portion.
 43. An object taking-out mechanismfor taking out an object from a pack in which the object is accommodatedin a wrapping member; the mechanism comprising an opening mechanism formaking a cut in the wrapping member, and a pushing mechanism for pushingout the object through the cut.